(88 days)
The Cup Electrodes are intended for non-invasive use with recording and monitoring equipment, (active and reference), of Electromyography (EMG), Electroencephalograph (EEG) and Evoked Potentials.
A cutaneous electrode is an electrode that is applied directly to a patient's skin to record physiological signals. In other words cutaneous devices are used in the acquisition of signals for the purpose of monitoring and recording Electroencephalograph (EEG), Electroencephalography (EEG), and Evoked Potentials (EP) and the electroencephalographic/evoked potentials reading is a completely non-invasive procedure that can be applied repeatedly to patients, normal adults, and children with virtually no risk or limitation. The electrodes are delivered non sterile and are available in reusable and disposable versions.
This document describes the acceptance criteria and study information for Technomed Europe's Cutaneous Electrodes (Cup Electrodes).
1. Table of Acceptance Criteria and Reported Device Performance:
The provided text describes a 510(k) submission for a cutaneous electrode (Cup Electrodes). In the context of a 510(k) submission for this type of device, the "acceptance criteria" are typically demonstrating substantial equivalence to a legally marketed predicate device. This is primarily achieved through non-clinical bench testing to confirm performance characteristics. The document does not provide specific quantitative acceptance criteria or detailed device performance metrics in a structured table.
However, based on the information provided, the implicit acceptance criteria are:
- Substantial Equivalence: The design, materials, chemical composition, packaging, and other technological characteristics are equivalent to the predicate device (K061148: Rhythmlink Disc Electrodes).
- Performance Characteristics: The device confirms its performance characteristics through bench testing.
- Safety and Effectiveness: The device is deemed safe and effective for its intended use.
The reported device performance is that the "comparison to the predicate devices demonstrate that the cup electrodes are safe and effective and are substantially equivalent to the predicate devices."
2. Sample Size Used for the Test Set and Data Provenance:
The document states, "Technomed Europe has been bench testing the Cup Electrode to confirm performance characteristics of this device."
- Sample Size for the Test Set: Not specified. The document does not provide a number of units tested or a breakdown of the tests conducted.
- Data Provenance: The bench testing was conducted by Technomed Europe. This is a non-clinical, in-house study. The country of origin for the data is The Netherlands, where Technomed Europe is located. The study is prospective in nature, as it involves testing a newly developed device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable. The device is a cutaneous electrode, and its performance evaluation for substantial equivalence primarily relies on non-clinical bench testing rather than the establishment of a "ground truth" by experts in the context of diagnostic interpretation. The evaluation focuses on physical and electrical properties, not interpretive results requiring expert consensus.
4. Adjudication Method for the Test Set:
This information is not applicable. Adjudication methods like '2+1' or '3+1' are typically used in clinical studies where multiple readers or experts evaluate a case and their opinions need to be reconciled to establish a ground truth. Since this product involves bench testing and not clinical interpretation by experts, an adjudication method is not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools where human readers (e.g., radiologists) interpret cases with and without AI assistance. The Technomed Europe Cup Electrodes are physical medical devices (electrodes) used for signal acquisition, not diagnostic interpretation, and therefore, an MRMC study is not relevant to their evaluation. Furthermore, the device does not involve AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No, a standalone (algorithm only) performance study was not done. This device is not an algorithm or AI system. It is a physical medical device. The "performance" assessment focuses on its physical and electrical characteristics through bench testing, not algorithmic performance.
7. The Type of Ground Truth Used:
The concept of "ground truth" as typically understood in diagnostic AI (e.g., pathology, outcomes data, expert consensus) is not directly applicable here. For this device, the "ground truth" or reference standards for performance are established through:
- Predicate Device Characteristics: The design, materials, and technological characteristics of the legally marketed predicate device (K061148: Rhythmlink Disc Electrodes) serve as a de facto reference for substantial equivalence.
- Bench Testing Standards: Industry standards and accepted methodologies for evaluating the physical and electrical performance of cutaneous electrodes would be the "ground truth" for the non-clinical tests performed.
8. The Sample Size for the Training Set:
This information is not applicable. A "training set" refers to data used to train machine learning models. This device is a physical electrode and does not involve any machine learning components, so there is no training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable, as there is no training set for this device.
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| Attachment C: | 510(k) Summary | K072016 |
|---|---|---|
| Manufacturer: | Technomed EuropeAmerikalaan 716199 AE Maastricht AirportThe Netherlands | OCT 19 2007 |
| Submitted by: | Technomed EuropeAmerikalaan 716199 AE Maastricht AirportThe NetherlandsTel.: (+31) 43-408 6868Fax: (+31) 43-408 6888 | |
| Contact person: | Mr. Maurice RoostManager Research & DevelopmentE-mail: mroost@technomed.nl | |
| Date: | 07 September, 2007 | |
| Proprietary Name: | Cutaneous Electrodes | |
| Common/usual Name: | Cup Electrodes | |
| Classification Name: | Cutaneous Electrode is classified as class II per21 CFR section 882.1320. Product code GXY. | |
| Substantial Equivalence: | K061148: Rhythmlink Disc Electrodes | |
| Device description: | A cutaneous electrode is an electrode that is applied directly toa patient's skin to record physiological signals. In other wordscutaneous devices are used in the acquisition of signals for thepurpose of monitoring and recording Electroencephalograph(EEG), Electroencephalography (EEG), and EvokedPotentials (EP) and the electroencephalographic/evokedpotentials reading is a completely non-invasive procedure thatcan be applied repeatedly to patients, normal adults, andchildren with virtually no risk or limitation. The electrodes aredelivered non sterile and are available in reusable anddisposable versions. | |
| Reusable: | Reusable Cup Electrodes have a disc manufactured with avariety of materials which include: silver, Ag/AgCl, GoldPlated. The disc is permanently adhered to a lead wire. Theinsulated lead wires terminate using a molded touch proofconnector (DIN 42-802) for electrical safety. The cupelectrode may be sterilized using steam autoclave. The cupelectrodes are available in an adult version and a pediatricversion. | |
| Disposable: | These electrode are for single patient use only. DisposableCup Electrodes have a disc manufactured of molded ABS,Ag/AgCl Plated. The disc is permanently adhered to a leadwire. The insulated lead wires terminate using a molded touchproof connector (DIN 42-802) for electrical safety. |
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| Intended Use: | The Cup Electrodes are intended for non-invasive use withrecording and monitoring equipment, (active and reference),of Electromyography (EMG), Electroencephalograph (EEG)and Evoked Potentials (EP). |
|---|---|
| Comparison to predicates: | The design, materials, chemical composition, packaging andother technological characteristics of the subject device isequivalent to those of the predicate devices. |
| Non-clinical data: | Technomed Europe has been bench testing the Cup Electrodeto confirm performance characteristics of this device. |
| Conclusion: | The comparison to the predicate devices demonstrate that thecup electrodes are safe and effective and are substantiallyequivalent to the predicate devices. |
:
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the left side of the image.
OCT 1 9 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Technomed Europe c/o Mr. Maurice Roost, Manager Research & Development Amerikalaan 71 6199 AE Maastricht Airport The Netherlands
Re: K072016
Trade/Device Name: Cup Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode. Regulatory Class: Class II Product Code: GXY Dated: July 20, 2007 Received: July 23, 2007
Dear Mr. Roost:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21
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CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours. Mark N. Melkerson
Director, Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and -Radiological Health-
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Cup Electrodes
Indications For Use:
The Cup Electrodes are intended for non-invasive use with recording and monitoring equipment, (active and reference), of Electromyography (EMG), Electroencephalograph (EEG) and Evoked Potentials.
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) | |
| AND/OR | |
| Over-The-Counter Use | |
| (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | K012014 |
|---|---|
| --------------- | --------- |
| Page 1 of | 1 |
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§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).